BS EN 61010-2-040:2015 BSI Standards Publication Safety requirements for electrical equipment for measurement, control, and laboratory use Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials BRITISH STANDARD BS EN 61010-2-040:2015 National foreword This British Standard is the UK implementation of EN 61010-2-040:2015 It is identical to IEC 61010-2-040:2015 It supersedes BS EN 61010-2-040:2005, which will be withdrawn on 11 August 2018 The UK participation in its preparation was entrusted to Technical Committee EPL/66, Safety of measuring, control and laboratory equipment A list of organizations represented on this committee can be obtained on request to its secretary This publication does not purport to include all the necessary provisions of a contract Users are responsible for its correct application © The British Standards Institution 2015 Published by BSI Standards Limited 2015 ISBN 978 580 78856 ICS 11.080.10; 19.080; 71.040.10 Compliance with a British Standard cannot confer immunity from legal obligations This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 September 2015 Amendments/corrigenda issued since publication Date Text affected BS EN 61010-2-040:2015 EUROPEAN STANDARD EN 61010-2-040 NORME EUROPÉENNE EUROPÄISCHE NORM September 2015 ICS 19.080; 71.040.10 Supersedes EN 61010-2-040:2005 English Version Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040 Particular requirements for sterilizers and washer-disinfectors used to treat medical materials (IEC 61010-2-040:2015) Règles de sécurité pour appareils électriques de mesurage, de régulation et de laboratoire - Partie 2-040: Exigences particulières pour stérilisateurs et laveurs désinfecteurs utilisés pour traiter le matériel médical (IEC 61010-2-040:2015) Sicherheitsbestimmungen für elektrische Mess-, Steuer-, Regel- und Laborgeräte - Teil 2-040: Besondere Anforderungen an Sterilisatoren und ReinigungsDesinfektionsgeräte für die Behandlung medizinischen Materials (IEC 61010-2-040:2015) This European Standard was approved by CENELEC on 2015-08-11 CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CENELEC member This European Standard exists in three official versions (English, French, German) A version in any other language made by translation under the responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom European Committee for Electrotechnical Standardization Comité Européen de Normalisation Electrotechnique Europäisches Komitee für Elektrotechnische Normung CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels © 2015 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members Ref No EN 61010-2-040:2015 E BS EN 61010-2-040:2015 EN 61010-2-040:2015 European foreword The text of document 66/570/FDIS, future edition of IEC 61010-2-040, prepared by IEC/TC 66 "Safety of measuring, control and laboratory equipment" was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN 61010-2-040:2015 The following dates are fixed: • latest date by which the document has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2016-05-11 • latest date by which the national standards conflicting with the document have to be withdrawn (dow) 2018-08-11 This document supersedes EN 61010-2-040:2005 Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights CENELEC [and/or CEN] shall not be held responsible for identifying any or all such patent rights Endorsement notice The text of the International Standard IEC 61010-2-040:2015 was approved by CENELEC as a European Standard without any modification In the official version, for Bibliography, the following notes have to be added for the standards indicated: IEC 60079 NOTE Harmonized in EN 60079 series IEC 60335-2-4 NOTE Harmonized as EN 60335-2-4 IEC 60335-2-5 NOTE Harmonized as EN 60335-2-5 IEC 60335-2-7 NOTE Harmonized as EN 60335-2-7 IEC 60335-2-11 NOTE Harmonized as EN 60335-2-11 IEC 60335-2-58 NOTE Harmonized as EN 60335-2-58 IEC 60601-1 NOTE Harmonized as EN 60601-1 IEC 60825-1 NOTE Harmonized as EN 60825-1 IEC 61010-2-010 NOTE Harmonized as EN 61010-2-010 IEC 61058 NOTE Harmonized in EN 61058 series IEC 61672-1 NOTE Harmonized as EN 61672-1 BS EN 61010-2-040:2015 EN 61010-2-040:2015 IEC 61672-2 NOTE Harmonized as EN 61672-2 IEC 62061 NOTE Harmonized as EN 62061 IEC 62304 NOTE Harmonized as EN 62304 ISO 10472 NOTE Harmonized in EN ISO 10472 series ISO 12100:2010 NOTE Harmonized as EN ISO 12100:2010 ISO 13849-2 NOTE Harmonized as EN ISO 13849-2 ISO 14971 NOTE Harmonized as EN ISO 14971 BS EN 61010-2-040:2015 EN 61010-2-040:2015 Annex ZA (normative) Normative references to international publications with their corresponding European publications The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application For dated references, only the edition cited applies For undated references, the latest edition of the referenced document (including any amendments) applies NOTE When an International Publication has been modified by common modifications, indicated by (mod), the relevant EN/HD applies NOTE Up-to-date information on the latest versions of the European Standards listed in this annex is available here: www.cenelec.eu Publication Year Title EN/HD Year Addition to Annex ZA of EN 61010-1:2010: IEC 61770 - Electric appliances connected to the water mains - Avoidance of backsiphonage and failure of hose-sets EN 61770 - IEC 62471 - Photobiological safety of lamps and lamp systems EN 62471 - IEC/TR 62471-2 - Photobiological safety of lamps and lamp systems Part 2: Guidance on manufacturing requirements relating to non-laser optical radiation safety - - ISO 3585 - Borosilicate glass 3.3 - Properties - - ISO 4126-1 - Safety devices for protection against excessive pressure Part 1: Safety valves EN ISO 4126-1 - ISO 4126-2 - Safety devices for protection against excessive pressure Part 2: Bursting disc safety devices EN ISO 4126-2 - –2– BS EN 61010-2-040:2015 IEC 61010-2-040:2015 © IEC 2015 CONTENTS FOREWORD Scope and object Normative references Terms and definitions Tests Marking and documentation Protection against electric shock 14 Protection against mechanical HAZARDS and against HAZARDS related to mechanical functions 14 Mechanical resistance to shock and impact 19 Protection against the spread of fire 19 10 Equipment temperature limits and resistance to heat 19 11 Protection against HAZARDS from fluids 20 12 Protection against radiation, including laser sources, and against sonic and ultrasonic pressure 23 13 Protection against liberated gases, substances, explosion and implosion 25 14 Components 31 15 Protection by interlocks 32 16 H AZARDS resulting from application 32 17 R ISK assessment 32 Annexes 33 Annex G (informative) Leakage and rupture from fluids under pressure 33 Annex L (informative) Index of defined terms 34 Bibliography 35 Table 101 – Lamp or lamp systems considered photobiologically safe 24 Table 102 – Lamp or lamp systems considered photobiologically safe under certain conditions 24 BS EN 61010-2-040:2015 IEC 61010-2-040:2015 © IEC 2015 –3– INTERNATIONAL ELECTROTECHNICAL COMMISSION SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL, AND LABORATORY USE – Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials FOREWORD 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all national electrotechnical committees (IEC National Committees) The object of IEC is to promote international co-operation on all questions concerning standardization in the electrical and electronic fields To this end and in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC Publication(s)”) Their preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with may participate in this preparatory work International, governmental and nongovernmental organizations liaising with the IEC also participate in this preparation IEC collaborates closely with the International Organization for Standardization (ISO) in accordance with conditions determined by agreement between the two organizations 2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international consensus of opinion on the relevant subjects since each technical committee has representation from all interested IEC National Committees 3) IEC Publications have the form of recommendations for international use and are accepted by IEC National Committees in that sense While all reasonable efforts are made to ensure that the technical content of IEC Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any misinterpretation by any end user 4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications transparently to the maximum extent possible in their national and regional publications Any divergence between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter 5) IEC itself does not provide any attestation of conformity Independent certification bodies provide conformity assessment services and, in some areas, access to IEC marks of conformity IEC is not responsible for any services carried out by independent certification bodies 6) All users should ensure that they have the latest edition of this publication 7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and members of its technical committees and IEC National Committees for any personal injury, property damage or other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC Publications 8) Attention is drawn to the Normative references cited in this publication Use of the referenced publications is indispensable for the correct application of this publication 9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of patent rights IEC shall not be held responsible for identifying any or all such patent rights International Standard IEC 61010-2-040 has been prepared by IEC technical committee 66: Safety of measuring, control and laboratory equipment It has the status of a group safety publication, as specified in IEC Guide 104 This second edition cancels and replaces the first edition published in 2005 This edition constitutes a technical revision This edition includes the following significant technical changes with respect to the previous edition: a) A new clause (4.3.2.101) has been added for non-electrical supplies and services b) Additional requirements for marking and documentation (Clause 5) have been added –4– BS EN 61010-2-040:2015 IEC 61010-2-040:2015 © IEC 2015 c) Additional requirements for protection against mechanical hazards (Clause 7) have been included d) Additional requirements for protection against radiation, including laser sources, and against sonic and ultrasonic pressure (Clause 12) have been included The text of this standard is based on the following documents: FDIS Report on voting 66/570/FDIS 66/576/RVD Full information on the voting for the approval of this standard can be found in the report on voting indicated in the above table This publication has been drafted in accordance with the ISO/IEC Directives, Part A list of all parts in the IEC 61010 series, published under the general title Safety requirements for electrical equipment for measurement, control, and laboratory use, can be found on the IEC website This Part 2-040 is intended to be used in conjunction with IEC 61010-1 It was established on the basis of the third edition (2010) Consideration may be given to future editions of, or amendments to, IEC 61010-1 Where a particular subclause of Part is not mentioned in this Part 2-040, that subclause applies as far as is reasonable Where this part states “addition”, “modification”, “replacement”, or “deletion”, the relevant requirement, test specification or note in Part should be adapted accordingly In this standard: 1) the following print types are used: – requirements: in roman type; – NOTES: in small roman type ; – conformity and tests: in italic type; – terms used throughout this standard which have been defined in Clause 3: SMALL ROMAN CAPITALS 2) subclauses, figures, and tables which are additional to those in Part are numbered starting from 101; additional annexes are lettered starting from AA and additional list items are lettered from aa) The committee has decided that the contents of this publication will remain unchanged until the stability date indicated on the IEC website under "http://webstore.iec.ch" in the data related to the specific publication At this date, the publication will be • • • • reconfirmed, withdrawn, replaced by a revised edition, or amended BS EN 61010-2-040:2015 IEC 61010-2-040:2015 © IEC 2015 –5– SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL, AND LABORATORY USE – Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials Scope and object This clause of Part is applicable except as follows: 1.1.1 Equipment included in scope Replacement: Replace the existing text with the following: This part of IEC 61010 specifies safety requirements for electrical equipment intended for sterilization, washing, and disinfection of medical materials in the medical, veterinary, pharmaceutical and laboratory fields, when used under the environmental conditions of 1.4 Examples of such equipment include the following: a) sterilizers and disinfectors using steam, and/or hot water as the sterilant; b) sterilizers and disinfectors using toxic gas, toxic aerosol or toxic vapour as the sterilant; c) sterilizers and disinfectors using hot air or hot inert gas as the sterilant; and d) washer disinfectors 1.1.2 Equipment excluded from scope Addition: Add the following note to item f): NOTE IEC 60601-1 defines medical electrical equipment as follows: Electrical equipment, provided with not more than one connection to a particular supply MAINS and intended by its manufacturer to be used in the diagnosis, treatment, or monitoring of a patient; and that makes physical or electrical contact with the patient or transfers energy to or from the patient or detects such energy transfer to or from the patient Addition: Add the following new second paragraph: This part of IEC 61010 does not apply to the following types of equipment: aa) bb) cc) dd) equipment for use in hazardous atmospheres (see IEC 60079) but does apply to an atmosphere created inside equipment by a flammable sterilizing agent (see 13.0); laboratory equipment for the heating of materials for other purposes than sterilization or disinfection (see IEC 61010-2-010); laundry equipment (see IEC 60335-2-4, IEC 60335-2-7, IEC 60335-2-11, and ISO 10472), unless designed for disinfecting medical materials; dishwashers (see IEC 60335-2-5 and IEC 60335-2-58) BS EN 61010-2-040:2015 IEC 61010-2-040:2015 © IEC 2015 – 25 – a) Any part necessary for the correct operation of the equipment and supplied by the manufacturer as an integral part of such equipment, for example a pump, is fitted and operated as in normal use; b) Sound level meters used in the measurement conform either to type of IEC 61672-1 or, in the case of an integrating sound level meter, to type of IEC 61672-2; c) The test room is semi-reverberant, with a hard reflecting floor The distance between any wall or any other object and the surface of the equipment is not less than m; d) The equipment is tested with the combination of load and other operating conditions (for example, pressure, flow, temperature) which creates the maximum sound pressure level Installation instructions shall specify how the RESPONSIBLE BODY can ensure that the sound pressure level from equipment, at its point of use after installation, will not reach a value that could cause a HAZARD These instructions shall: 1) identify readily available and practicable protective materials or measures which can be used, including the fitting of noise-reducing baffles or hoods; 2) recommend that the sound pressure level be measured in normal use at the operator’s position and at a point m from the enclosure in a location that has the highest sound pressure level NOTE A sound pressure level of 80 dB above a reference sound pressure of 20 µPa is at present regarded by many authorities as the threshold at which a HAZARD can be caused Special means, such as the use of protective earpieces, can make a higher level non-hazardous to an operator Conformity is checked by inspection 13 Protection against liberated gases, substances, explosion and implosion This clause of Part is applicable except as follows: 13.1 Poisonous and injurious gases and substances Replacement: Replace the first paragraph by the following text: Equipment shall not liberate dangerous amounts of hazardous substances in NORMAL CONDITION or SINGLE FAULT CONDITION If potentially-hazardous substances are liberated, the OPERATOR shall not be exposed to a quantity of the substance that could cause harm If NORMAL operation of the equipment requires the discharge of hazardous substances, and if that discharge is intended to be managed by the RESPONSIBLE BODY in accordance with the manufacturer’s instructions, then such discharge is not considered to be liberation of hazardous substances Addition: Add the following new note and new paragraphs after the second paragraph: NOTE A HAZARD is considered to occur if toxic emissions can exceed the short-term exposure limit (STEL) or the long-term exposure limit (LTEL) for the gas under consideration Toxic emissions include all sterilizing and disinfecting agents that have defined STEL or LTEL values For equipment using highly toxic, flammable, or explosive chemicals such as pure ethylene oxide, risk assessment shall be carried out for both NORMAL CONDITION and SINGLE FAULT CONDITION to determine if leakage could cause a toxic or explosive atmosphere – 26 – BS EN 61010-2-040:2015 IEC 61010-2-040:2015 © IEC 2015 See also 7.102 a) relating to access to the CHAMBER during an OPERATING CYCLE , 7.104 relating to preventing the start of a new OPERATING CYCLE , and paragraph of Clause relating to a possible fire HAZARD from hot items falling out of equipment Addition: Add the following new subclauses: 13.1.101 13.1.101.1 CHAMBER discharge systems Discharge from the CHAMBER Discharge from the CHAMBER shall not cause a HAZARD Conformity is checked by inspection and by examination of the installation instructions 13.1.101.2 Failure of a CHAMBER exhaust system If a HAZARD could arise from a failure of a CHAMBER exhaust system, audible and visible alarm signals, independent from the supply MAINS , shall warn of failure of any system that is designed to remove a discharge of sterilant gas from the CHAMBER Examples of such failure are malfunction of an extractor fan, obstruction of a flow duct, and failure of the power supply If a HAZARD could arise from a failure of MAINS supply, the exhaust system should be supplied by an emergency power system During a failure of a CHAMBER exhaust system, it shall not be possible to initiate an OPERATING CYCLE If an OPERATING CYCLE is already in progress and at a stage where sterilant gas has been admitted to the CHAMBER , access to the LOAD shall be prevented until the exhaust system is again operational and a flushing stage has been completed Conformity is checked by provoking all possible single faults in turn, and confirming that: a) the alarm signals operate even with the supply MAINS disconnected; b) the OPERATING CYCLE cannot be started; c) access to the LOAD is prevented 13.1.101.3 Protection from gases liberated from a drain Discharge from the CHAMBER into the part of a drainage system which forms part of the equipment and its connection to the building drainage system shall not cause a HAZARD Installation instructions shall state that any venting of the drain shall be to a safe place NOTE National and local regulations and other codes can specify additional requirements for drainage systems Conformity is checked by: a) inspecting the drainage system and its venting; b) connecting the equipment to a drain that complies with the manufacturer’s specification; c) measuring the concentration of sterilant gas at the connection to the drain, to check that STEL and LTEL values are not exceeded 13.1.101.4 Local exhaust ventilation If a HAZARD could arise from fugitive emissions, the equipment shall be provided with means to connect a local exhaust ventilation system to remove them BS EN 61010-2-040:2015 IEC 61010-2-040:2015 © IEC 2015 – 27 – The manufacturer’s installation instructions shall warn the RESPONSIBLE BODY that: a) additional local exhaust ventilation can also be required in storage areas for sterilant gas; b) the discharge from a local exhaust ventilation system is located so as not to cause a HAZARD NOTE This local exhaust ventilation system can also be designed to be activated if the STEL value of the sterilant is exceeded Conformity is checked by inspection 13.1.102 LOAD access after a fault The manufacturer shall provide instructions to ensure safe access to the LOAD if a fault occurs during an OPERATING CYCLE Conformity is checked by analysis of the control system and by inspection 13.1.103 13.1.103.1 HAZARDS arising from the use of toxic sterilant CHAMBER leakage If leakage from the CHAMBER could cause a HAZARD , each OPERATING CYCLE shall include a check, before sterilant gas is admitted to the CHAMBER , to detect any potentially hazardous leakage Detection of leakage that could cause a HAZARD shall cause the equipment to revert to a safe condition NOTE The relevant values specified for leakage rates will depend on a number of factors, for example the volume of the CHAMBER , the OPERATING CYCLE , and the nature of the sterilant gas, including its STEL and LTEL values Conformity is checked by analysis of the OPERATING CYCLE and by testing all means provided for leak detection Equipment operating above atmospheric pressure shall have a means, such as a non-return valve in the air inlet pipe, to prevent the escape of toxic sterilant gas from the CHAMBER Conformity is checked by inspection 13.1.103.2 Protection against gases liberated from the LOAD It shall not be possible to open the door until the sterilant concentration has been reduced to a level where the LOAD will not present a HAZARD to the OPERATOR when the STERILIZER is unloaded The manufacturer shall advise the RESPONSIBLE BODY of any change required to take account of the very different gas absorption characteristics of materials processed NOTE One method of ensuring this is for the sterilant removal stage to be followed by a stage during which further sterilant is removed by flushing with filtered air or inert gas The air or gas can either be passed continuously through the chamber or there can be multiple admissions, each followed by evacuation Conformity is checked by inspection and by analysis of the OPERATING CYCLE and by measurement of the sterilant concentration at 170 cm from the floor and m directly in front of the middle of the door at the least favourable time after releasing a seal or opening the door 13.1.103.3 Failure of room ventilation system If room ventilation is required to prevent a HAZARD , means shall be provided so that in the event of its failure: – 28 – BS EN 61010-2-040:2015 IEC 61010-2-040:2015 © IEC 2015 a) the equipment will go to a safe state; b) a new OPERATING CYCLE cannot be started while the failure continues to exist; c) this is indicated by both audible and visible alarm signals NOTE Measurement of air flow can be used to identify a failure Conformity is checked by inspection, and by simulating failure of the room ventilation system 13.1.103.4 Materials in contact with sterilant Material used in the construction of the sterilizer which can come in contact with sterilant shall not react with sterilant or carrier gas to an extent that material deterioration could lead to leakage in sufficient quantity to cause STEL or LTEL values to be exceeded The manufacturer’s instructions shall state that material used in the installation of the sterilizer which can come in contact with sterilant must not react with sterilant or carrier gas to an extent that material deterioration could lead to leakage in sufficient quantity to cause STEL or LTEL values to be exceeded Conformity is checked by inspection, including inspection of the manufacturer’s installation instructions and by examination of data accumulated by the manufacturer during failure-mode analysis and during tests, to demonstrate that the materials used are compatible with sterilant and carrier gases 13.1.104 Pathogenic substances In NORMAL CONDITION or SINGLE FAULT CONDITION , emission of aerosols or fluids from equipment shall not cause a HAZARD If additional means are required to control emissions, they shall be specified in the manufacturer’s installation instructions NOTE For some applications, visual examination for aerosols and fluids can be.sufficient Conformity is checked by inspection and test, and by examination of the manufacturer’s instructions 13.2 Explosion and implosion Addition: Add the following subclauses: 13.2.101 Materials in contact with sterilant The equipment shall be made of materials which, in normal use, will not react with sterilant or carrier gases in a manner and to an extent that could lead to a change in pressure (either by ignition or exothermic reaction) that could result in explosion or implosion The manufacturer’s instructions shall state that materials used in the installation of the sterilizer which can come in contact with sterilant must not react with sterilant or carrier gas to an extent that material deterioration could result in explosion or implosion For the selection of materials for pressure-retaining parts and their integral attachments, attention shall be paid to the effects of galvanic attack and different rates of expansion when dissimilar metals are in contact Copper or copper alloys containing more than 65 % mass fraction of copper are not suitable if the sterilant gas contains acetylene BS EN 61010-2-040:2015 IEC 61010-2-040:2015 © IEC 2015 – 29 – Conformity is checked by inspection, and by examination of data accumulated by the manufacturer during failure-mode analysis and during tests, to demonstrate that the materials used are compatible with sterilant and carrier gases 13.2.102 Explosion, implosion and fire of toxic gas sterilizers 13.2.102.1 Flammable sterilants Equipment intended for use with flammable sterilants shall have no source of ignition within the CHAMBER , its sterilant connections, or its exhaust piping If during a process the mixture of air with the flammable sterilant could lead to fire or explosion in NORMAL CONDITION or SINGLE FAULT CONDITION , the sterilant concentration shall be reduced to below the flammable limit before air is admitted at the end of the OPERATING CYCLE The OPERATING CYCLE shall also ensure that progress to the next stage of the sterilization cycle cannot occur if there is a possibility of a fire or explosion HAZARD Conformity is checked by examination of the interior of the chamber and its sterilant and exhaust connections, by analysis of the OPERATING CYCLE , and by calculating the sterilant concentration at the time the air is admitted If a fire or explosion HAZARD could arise from a failure of the chamber exhaust system, the requirements of 13.1.101.2 apply Conformity is checked as specified in 13.1.101.2 13.2.102.2 Heating of flammable liquid sterilant Sterilant containers shall not be subjected to direct heating which could cause a HAZARD If a HAZARD could arise, flammable or explosive liquids, such as ethylene oxide, shall not be heated by an electrical heating element in direct contact with the liquid In NORMAL CONDITION or SINGLE FAULT CONDITION , parts of the equipment which could be contacted by the sterilant shall not reach a temperature at which fire, explosion, or other HAZARD could be caused NOTE This temperature will depend on the type of sterilant For example, the temperature limit for ethylene oxide is normally 70 °C to prevent polymerization or catalytic reaction Conformity is checked by inspection and examination of sterilant safety data and, in case of doubt, by temperature measurement Addition: Add the following new subclauses: 13.101 Other HAZARDS arising from the use of toxic sterilants NOTE A toxic HAZARD is considered to occur if toxic sterilant emissions can exceed STEL or LTEL for the gas under consideration Toxic sterilants include all sterilizing and disinfecting agents that have defined STEL or LTEL limits 13.101.1 Opening or disconnecting a sterilant supply system If a HAZARD could arise during disconnection or opening of the sterilant supply system, means (for example, purging) shall be provided to prevent the HAZARD from arising Conformity is checked by inspection – 30 – 13.101.2 BS EN 61010-2-040:2015 IEC 61010-2-040:2015 © IEC 2015 Gas blending For sterilizers operating with a sterilant which is a mixture of gases blended at the point of use, means shall be provided to ensure that no toxic, fire, or explosion HAZARD can arise as a result of incorrect mixing in NORMAL CONDITION or SINGLE FAULT CONDITION Conformity is checked by analysis and measurement of each gas in the mixture in NORMAL CONDITION and SINGLE FAULT CONDITION (see 4.4.2.103) 13.101.3 Sterilant supply If a HAZARD could arise from uncontrolled or incorrect supply of sterilant, additional controls or mechanisms shall be provided to interrupt the sterilant supply to the CHAMBER and prevent the HAZARD NOTE In case of toxic or flammable gases this could be achieved by the use of non-return valve and a flame arrester or heat-sensitive cut-off valve NOTE National regulations can require automatic and manual valves on flammable gases Means shall be provided to dispense, connect and position containers of liquid sterilant without creating a HAZARD Conformity is checked by inspection, and by examination of data on rated sterilants 13.101.4 Supply from sterilant cartridges If a HAZARD could arise, means shall be provided to prevent access to the sterilant cartridge during the OPERATING CYCLE NOTE A cartridge is a single-use container of sterilant Conformity is checked by inspection 13.101.5 Isolation of any part of the sterilant supply system When any part of the sterilant gas supply system can be isolated and its maximum working pressure could be exceeded in NORMAL CONDITION or SINGLE FAULT CONDITION , it shall be protected by an overpressure safety device meeting the requirements of 11.7.4 NOTE A HAZARD can arise in cases where the isolated length of pipe is full of liquid Conformity is checked by inspection and as specified in 11.7.4 13.101.6 Failure of a sterilant supply control system A failure which could cause a HAZARD shall be indicated by a visible alarm signal It shall also cause the equipment to go to a safe state and it shall not be possible to initiate an OPERATING CYCLE while the failure exists Conformity is checked by inspection and test 13.102 Chemical dosing systems If a chemical dosing system is fitted, means shall be provided to replenish containers without creating a HAZARD Conformity is checked by inspection and by examination of the manufacturer’s instructions BS EN 61010-2-040:2015 IEC 61010-2-040:2015 © IEC 2015 – 31 – 14 Components This clause of Part is applicable except as follows: Addition: Add the following new subclauses: 14.101 PRESSURE VESSELS and shell boilers PRESSURE VESSELS and shell boilers shall comply with the pressure systems regulations, codes or standards applicable in the country of intended use (e.g EN 13445, EN 14222, and EN 12953 in the EU) If no national regulations, codes or standards exist, the equipment shall comply with the requirements of 11.7 Conformity is checked by inspection of the PRESSURE VESSEL or shell boiler and consideration of the relevant national and local regulations and codes 14.102 Access ports If an access port (for example, for injecting small quantities of chemicals into the CHAMBER ) can be opened and closed by an OPERATOR without the use of a TOOL , means shall be provided to prevent opening if conditions inside the equipment could cause a HAZARD NOTE a) Means can include: interlocks (see Clause 15); b) ensure inaccessibility during an OPERATING CYCLE ; c) fitting an interlocked cover over the port (see Clause 15) Conformity is checked by inspection and by examination of the design specification 14.103 Control systems If the setting of a control in NORMAL USE could cause a HAZARD , a warning marking (see 5.2) shall be provided To reduce the likelihood of the equipment being set in a way that could cause a HAZARD , access to the following functions (if provided), shall be limited by increasingly severe constraints Examples of possible constraint levels are given in brackets a) initiation of an OPERATING CYCLE [available to OPERATOR s]; b) selection of an OPERATING CYCLE [available to OPERATOR s or supervisors, as appropriate]; c) changing OPERATING CYCLE parameters [restricted to supervisors]; d) manual advance through an OPERATING CYCLE [restricted to suitably trained technicians]; e) maintenance [restricted to suitably trained service technicians]; f) changing the OPERATING CYCLE manufacturer's agent] programme [restricted to the manufacturer or Except for a) and b), the above functions shall require the use of different keys, codes or other equivalent means Higher-level TOOL s, keys or codes can allow access to lower levels Termination of an OPERATING CYCLE shall not require the use of a special TOOL , key or code – 32 – BS EN 61010-2-040:2015 IEC 61010-2-040:2015 © IEC 2015 It shall not be possible to disable safety devices during NORMAL USE , or while gaining access to the LOAD This applies both during manual advance of the OPERATING CYCLE and when under automatic control If operation can be either by manual advance or by an automatic controller, selection of the manual mode shall disable the automatic controller Automatic control is recommended for all equipment within the scope of this standard, because a manual control system could present serious HAZARDS to the OPERATOR from chemicals, toxic gas, hot gases, steam, or hot water Conformity is checked by inspection and test by operating the equipment to confirm that the safety devices cannot be disabled 14.104 Microprocessors Failure of a safety-related microprocessor shall not cause a HAZARD NOTE This requirement can be achieved by redundancy or diversity NOTE Guidance on safety related control systems using microprocessors and other software controlled devices is given in IEC 61508-3, ISO 13849-2, IEC 62061 and IEC 62304 If a battery is used to maintain a processor memory, no HAZARD shall arise as a result of loss of this power Conformity is checked by inspection, risk analysis, function of the circuit under evaluation and, in case of doubt, by simulating a fault 14.105 Asbestos No parts made of asbestos shall be used Conformity is checked by examination of the manufacturer’s data 15 Protection by interlocks This clause of Part is applicable 16 H AZARDS resulting from application This clause of Part is applicable 17 RISK assessment This clause of Part is applicable except as follows: Addition: Add the following item to the list of standards in the note: ISO 12100:2010, BS EN 61010-2-040:2015 IEC 61010-2-040:2015 © IEC 2015 – 33 – Annexes The annexes of Part are applicable, except as follows: Annex G (informative) Leakage and rupture from fluids under pressure This annex of Part is applicable except as follows: Replace the first paragraph by the following new paragraph: The requirements and tests of this annex are accepted in the USA, Canada, and in some other countries, as proof of conformity with national regulations relating to high pressures However, they not apply to shell boilers and PRESSURE VESSELS , for which there are separate and different national or local regulations – 34 – BS EN 61010-2-040:2015 IEC 61010-2-040:2015 © IEC 2015 Annex L (informative) Index of defined terms Additional defined terms: CHAMBER 3.2.101 LOAD 3.2.102 STERILIZER 3.2.103 PRESSURE VESSEL 3.2.104 OPERATING CYCLE 3.2.105 WASHER - DISINFECTOR 3.2.106 BS EN 61010-2-040:2015 IEC 61010-2-040:2015 © IEC 2015 – 35 – Bibliography Add the following publications: IEC 60079 (all parts), Explosive atmospheres IEC 60335-2-4, Household and similar electrical appliances – Safety – Part 2-4: Particular requirements for spin extractors IEC 60335-2-5, Household and similar electrical appliances – Safety – Part 2-5: Particular requirements for dishwashers IEC 60335-2-7, Household and similar electrical appliances – Safety – Part 2-7: Particular requirements for washing machines IEC 60335-2-11, Household and similar electrical appliances – Safety – Part 2-11: Particular requirements for tumble dryers IEC 60335-2-58, Household and similar electrical appliances – Safety – Part 2-58: Particular requirements for commercial electric dishwashing machines IEC 60601-1, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance IEC 60825-1, Safety of laser products – Part 1: Equipment classification and requirements IEC 61010-2-010, Safety requirements for electrical equipment for measurement, control and laboratory use – Part 2-010: Particular requirements for laboratory equipment for the heating of materials IEC 61508 (all parts), Functional safety of electrical/electronic/programmable electronic safetyrelated systems IEC 61672-1, Electroacoustics – Sound level meters – Part 1: Specifications IEC 61672-2, Electroacoustics – Sound level meters – Part 2: Pattern evaluation tests IEC 62061, Safety of machinery – Functional safety of safety-related electrical, electronic and programmable electronic control systems IEC 62304, Medical device software - Software life cycle processes ISO 2901, ISO metric trapezoidal screw threads – Basic profile and maximum material profiles ISO 2902, ISO metric trapezoidal screw threads – General plan ISO 2903, ISO metric trapezoidal screw threads – Tolerances ISO 2904, ISO metric trapezoidal screw threads – Basic dimensions ISO 10472 (all parts), Safety requirements for industrial laundry machinery ISO 12100:2010, Safety of machinery – General principles for design – Risk assessment and risk reduction – 36 – BS EN 61010-2-040:2015 IEC 61010-2-040:2015 © IEC 2015 ISO 13849-2, Safety of machinery – Safety-related parts of control systems – Part 2: Validation ISO 14971, Medical devices – Application of risk management to medical devices ISO 15223-2, Medical devices – Symbols to be used with medical device labels, labelling, and information to be supplied – Part 2: Symbol development, selection and validation EN 12953 (all parts), Shell boilers EN 13445 (all parts), Unfired pressure vessels EN 14222, Stainless steel shell boilers EN 1837, Safety of machinery Integral lighting of machines _ This page deliberately left blank This page deliberately left blank NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW British Standards Institution (BSI) BSI is the national body responsible for preparing British Standards and other standards-related publications, information and services BSI is incorporated by Royal Charter British Standards and other standardization products are published by BSI Standards Limited About us Revisions We bring together business, industry, government, consumers, innovators and others to shape their combined experience and expertise into standards -based solutions Our British Standards and other publications are updated by amendment or revision The knowledge embodied in our standards has been carefully assembled in a dependable format and refined through our open consultation process Organizations of all sizes and across all sectors choose standards to help them achieve their goals Information on standards We can provide you with the knowledge that your organization needs to succeed Find out more about British Standards by visiting our website at bsigroup.com/standards or contacting our Customer Services team or Knowledge Centre Buying standards You can buy and download PDF versions of BSI publications, including British and adopted European and international standards, through our website at bsigroup.com/shop, where hard copies can also be purchased If you need international and foreign standards from other Standards Development Organizations, hard copies can be ordered from our Customer Services team Subscriptions Our range of subscription services are designed to make using standards easier for you For further information on our subscription products go to bsigroup.com/subscriptions With British Standards Online (BSOL) you’ll have instant access to over 55,000 British and adopted European and international standards from your desktop It’s available 24/7 and is refreshed daily so you’ll always be up to date You can keep in touch with standards developments and receive substantial discounts on the purchase price of standards, both in single copy and subscription format, by becoming a BSI Subscribing Member PLUS is an updating service exclusive to BSI Subscribing Members You will automatically receive the latest hard copy of your standards when they’re revised or replaced To find out more about becoming a BSI Subscribing Member and the benefits of membership, please visit bsigroup.com/shop With a Multi-User Network Licence (MUNL) you are able to host standards publications on your intranet Licences can cover as few or as many users as you wish With updates supplied as soon as they’re available, you can be sure your documentation is current For further information, email bsmusales@bsigroup.com BSI Group Headquarters 389 Chiswick High Road London W4 4AL UK We continually improve the quality of our products and services to benefit your business If you find an inaccuracy or ambiguity within a British Standard or other BSI publication please inform the Knowledge Centre Copyright All the data, software and documentation set out in all British Standards and other BSI publications are the property of and copyrighted by BSI, or some person or entity that owns copyright in the information used (such as the international standardization bodies) and has formally licensed such information to BSI for commercial publication and use Except as permitted under the Copyright, Designs and Patents Act 1988 no extract may be reproduced, stored in a retrieval system or transmitted in any form or by any means – electronic, photocopying, recording or otherwise – without prior written permission from BSI Details and advice can be obtained from the Copyright & Licensing Department Useful Contacts: Customer Services Tel: +44 845 086 9001 Email (orders): orders@bsigroup.com Email (enquiries): cservices@bsigroup.com Subscriptions Tel: +44 845 086 9001 Email: subscriptions@bsigroup.com Knowledge Centre Tel: +44 20 8996 7004 Email: knowledgecentre@bsigroup.com Copyright & Licensing Tel: +44 20 8996 7070 Email: copyright@bsigroup.com